MAUDE Adverse Event Report: MALEM MEDICAL MALEM BEDWETTING ALARM

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Type  Injury  

Event Description

Oh my god! what a dreadful device.This malem ultimate bedwetting alarm burnt my son on his neck and chest.We have used it for just 2 days and the batteries became so hot that the back of the alarm unit overheated and burnt him.This device is defective and i would like the fda to call for a unit and test it by themselves.My child had to be rushed to the doctor for treatment because of this flimsy alarm.The malem alarm must be recalled from the us market to avoid anyone else from getting hurt.Fyi, i bought this product from the bedwetting store.Their website is (b)(4).

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6975687
• MDR Text Key: 90293300
• Report Number: MW5072921
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR
• Patient Weight: 23